Committee on Issues in Organ Donor Intervention Research. Presented by: Richard D. Hasz Vice President, Clinical Services

Committee on Issues in Organ Donor Intervention Research Presented by: Richard D. Hasz Vice President, Clinical Services

Living Organ Donors 5,527 U.S. National Trends in Organ Donation Living vs. Deceased Organ Donors 2016 * 1995 2016 * Deceased Organ Donors 9,884 12,000 10,000 8,000 6,000 4,000 2,000 9,079 8,017 8,085 8,596 7,989 8,022 8,126 8,143 6,622 6,631 7,150 7,593 8,268 7,943 6,828 6,895 6,731 5,985 6,561 7,004 6,023 4,569 5,048 6,315 6,218 6,609 5,867 5,989 5,4795,793 5,824 5,990 5,363 5,418 6,080 6,190 6,457 5,819 3,804 4,067 5,957 5,527 3,496 9,884 Waiting List Deaths 2,036 0 Living Donors Deceased Donors Source: Based on OPTN data as projected through 2016. Count based upon candidates.

NUMBER OF DECEASED DONORS U.S. Experience Deceased Organ Donors By Donor Type 1996 2015 SCD ECD DCD 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: Based on OPTN data through December 31, 2015. YEAR

U.S. Deceased Organ Donors By Cause of Death CVA Only 1995 2015 4,000 3,500 3,336 3,355 3,308 3,206 3,178 3,049 3,000 2,612 2,631 2,635 2,767 3,127 2,932 2,833 2,761 2,782 2,671 2,500 2,000 1,500 1,000 500 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: Based on OPTN data as through December 31, 2015.

U.S. Deceased Organ Donors By Cause of Death Trauma Only 2000 2015 3,500 3,000 2,500 2,520 2,545 2,610 2,617 2,794 2,908 3,058 3,026 2,793 2,670 2,720 2,685 2,628 2,681 2,646 2,709 2,000 1,500 1,000 500 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: Based on OPTN data through December 31, 2015.

U.S. Deceased Organ Donors By Cause of Death Anoxia Only 2000 2015 4,000 3,500 3,429 3,000 2,500 2,278 2,436 2,599 2,900 2,000 1,500 1,000 500 619 697 741 855 1,024 1,147 1,348 1,489 1,732 1,893 1,942 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: Based on OPTN data through December 31, 2015.

Organ Donors by Cause of Death Trend GLDP 99 103 108 110 112 125 128 123 123 126 129 129 132 131 133 130 132 129 135 147 146 150 146 140 131 130 127 134 138 140 131 129 128 127 129 135 145 152 161 157 159 159 169 164 169 167 168 167 163 156 150 148 155 164 163 165 159 165 170 171 174 183 181 190 181 179 170 179 182 184 190 190 206 203 207 214 215 207 215 211 215 210 201 206 192 190 185 179 193 205 207 221 226 232 244 244 248 270 286 295 282 280 293 178 176 173 184 188 183 181 186 183 178 167 170 160 166 166 170 168 173 174 170 171 179 185 186 181 174 178 165 159 151 143 142 145 134 132 127 130 129 131 134 135 135 136 138 134 135 136 141 140 142 133 128 124 126 129 127 132 134 128 120 121 121 128 136 154 152 148 151 152 149 150 147 148 146 142 140 127 136 139 135 131 133 139 148 146 151 152 153 151 144 139 142 141 143 139 131 130 129 126 127 132 129 140 127 129 127 126 128 128 122 125 118 122 126 122 122 118 121 121 118 119 113 107 107 100 99 103 106 104 103 109 115 116 117 120 114 119 116 121 124 123 128 124 124 120 122 127 142 135 132 130 128 136 129 127 128 127 131 127 119 125 125 124 115 107 109 109 105 110 104 104 110 108 110 108 112 115 121 118 115 111 110 106 101 97928783 81 7375 81 83 889088 92 99102 103 108 104 100 94 89 89 0 50 100 150 200 250 300 350 1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 # Organ Donors (Previous 12 Months) Month / Year Anoxia Cerebrovascular/Stroke Head Trauma Other Causes of Death Excluded

1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 Organ Donors - Cardiovascular Deaths (Previous 12 Months) GLDP Anoxic Organ Donors w/ Cardiovascular Mechanism of Death Trend 180 160 140 120 100 80 7676 7981 71 89 92 87 84 8586868685 89 9091 9393 89 84858485 113 111 105 105 98 100 101 9595 91 82 83 8789 86 88 87 85 86 88 9091 86 8076 78 78 74 69 89 939696 130 131 126 127 123 125 120 117 119120 122 120121 118 115 104 108 107 109 112 113 106 110 111 110 109 112 107 106 102 102 113 117 115 124 125 128 163 152 154 153 147 143 136 136 138 60 40 20 0 Month / Year

1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 Organ Donors Drug Overdose Deaths (Previous 12 Months) GLDP Anoxic Organ Donors w/drug Overdose 120 Mechanism of Death Trend 100 104 102 100 95 9595 80 60 40 20 16 1719191921 20 18181817 18 19 18 17 1818 17 20 2223 2221201717 18 17171714 1515 18 17 181921 2020 25 28 36 34 38 4042 4545 47 46 47 4545 40 42 3636 37 35 34 32 3536 34 3331 33 3435 4040 434343 49 5 55 585961 57 525252 54 53 4747 55 60 75 70 66 80 8183 0 Month / Year

Deceased Donor Kidneys Recovered in the U.S. 1/1/2000 10/31/2016 3,500 3,000 2,500 2,000 1,500 1,000 500 1,627 1,578 1,500 1,668 2,084 2,211 2,368 Discarded 2,630 2,608 2,763 2,641 2,646 2,763 2,734 2,888 3,157 3,264 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Discarded

58 OPO Donation Service Areas in the U.S. 321 million people 9,080 Deceased Donors (2015) 5,988 Living Donors (2015) 30,973 Transplants (2015) OPO Data Population Bases from 1.3 Million to 19.8 Million Deceased Donors Recovered ranged from 40 to 483 Donors Donors per million (DPM) ranged from 17.0 to 44.0; U.S. Average 29.4

Organ Procurement Organization Interpretive Guidance 486.324(a)- 486.324(d) May 23, 2014 486.324(a)- While an OPO may have more than 1 board, the OPO must have an advisory board that has both the authority described in paragraph (b) of this section and the following membership: 486.324(a)1-Members who represent hospital administrators, either intensive care or emergency room personnel, tissue banks, and voluntary health associations in the OPO s DSA 486.324(a)2- Individuals who represent the public residing in the OPO s DSA 486.324(a)3- A physician with knowledge, experience, or skill in the field of human histocompatibility or an individual with a doctorate degree in biological science and with knowledge, experience or skills in the field of human histocompatibility 486.324(a)4-A neurosurgeon or other physician with knowledge or skills in the neurosciences 486.324(a)5- A transplant surgeon representing each transplant hospital in the service area with which to OPO has arrangements to coordinate its activities. The transplant surgeon must have practicing privileges and perform transplants in the transplant hospital represented 486.324(a)6- An organ donor family member

OPOs PUBLIC TRUST Donor Hospitals Transplant Centers

YEAR U.S. Organ Donor Experience DBD & DCD Donors 2002 2016 (projected through year end 2016) Total Deceased Organ Donors = 119,542 BD (n=106,137) DCDs (n=13,405) 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 6,187 6,000 6,757 7,062 7,036 7,069 7,002 7,102 7,140 7,029 270 190 7,304 7,294 7,375 393 8,195 7,585 (6,457) (6,190) 1,206 1,107 1,057 941 920 849 1,292 791 1,494 (8,143) (8,126) (7,943) (8,022) (7,989) (8,085) 642 (8,017) (7,593) 564 (7,150) (9,884) 1,689 (9,079) (8,596) (8,268) 0 2,000 4,000 6,000 8,000 10,000 NUMBER OF ORGAN DONORS

Transplant recipients may be participating in clinical studies designed to improve transplant outcomes. If the gifts cannot be used for transplantation or therapy, I authorize their use for research and/or education purposes. Yes No Management of the donor may include research measures designed to study ways of improving organ transplant outcomes.

GTEx Pilot Project Participants Three biospecimen source sites to collect tissues; GLDP, LifeNet of Virginia, Drexel University College of Medicine. A laboratory data analysis center A coordinating center, led by the National Cancer Institute's Cancer Human Biobank (cahub) Specimens shipped to cahub A portion of each sent to the laboratory, data analysis center, and coordinating center for molecular analysis.

Ideal Process for Organ Donation Education (General Public / Healthcare Professionals) Detection/Declaration of Death/Referral to OPO Donor Evaluation by OPO Coordinator Family Approach/Consent Clinical Donor Management Matching/Allocation Surgical Recovery/Preservation/T ransportation Transplantation Case Follow-Up

The care of the potential donor is essentially the simultaneous care of multiple recipients. Source: Wood et al. Care of the Potential Organ Donor. N Engl J Med 2004; 351: 2730-2739.

Aggressive Care Plan From the moment brain death is declared, the emphasis shifts from saving the patient s life, to maintaining the family s option to donate by optimizing end-organ function for possible transplantation. Acid Base Abnormalities Oliguria Oxygenation Excessive Urinary Output Hypothermia Impaired Gas Exchange Hypotension DIC Electrolyte Imbalances Hormonal Changes

Observed Organs Transplanted per 100 Donors U.S. SRTR Adjusted OPO OTPD Model 325 1/1/2014 12/31/2015 OTPD Significantly Higher Than Expected OTPD as Expected OTPD Significantly Lower Than Expected 300 275 250 225 225 250 275 300 325 Source: SRTR Expected Organs Transplanted per 100 Donors

Organ Allocation Pre-Recovery Intra-Operative Post-Recovery

OPO Begins Organ Offer Process OPO sends an electronic notification to a selected range of potential recipients. The primary contact for each transplant center will receive a voice and text notification. OPO sends out electronic notifications on the match results page. Prominent display of donor blood type. The candidate with the primary offer is highlighted.

1/08 3/08 5/08 7/08 9/08 11/08 1/09 3/09 5/09 7/09 9/09 11/09 1/10 3/10 5/10 7/10 9/10 11/10 1/11 3/11 5/11 7/11 9/11 11/11 1/12 3/12 5/12 7/12 9/12 11/12 1/13 3/13 5/13 7/13 9/13 11/13 1/14 3/14 5/14 7/14 9/14 11/14 1/15 3/15 5/15 7/15 9/15 11/15 1/16 3/16 5/16 7/16 # High Risk Organ Donors / # Organ Donors (Previous 12 Months) 40% 35% 30% 25% 20% 15% 10% 5% 0% % High Risk Organ Donor Trend GLDP Rolling 12 month avg Month / Year

Summary Donor Pool and Utilization Challenge Require DIR to increase transplants Guidance for Donor Hospital Policies Central Oversight to Assist Researchers & OPOs Organ Allocation Dynamics